| CTRI Number |
CTRI/2025/02/081324 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comapring The Effect Between Yashtimadhu Ghrit And Shatdhaut Ghrit In The Management Of Parikartika also known as acute fissure in ano |
|
Scientific Title of Study
|
A Comparative Study Of Effect Of Yashtimadhu Ghrit And Shatdhaut Ghrit Locally In The Management Of Parikartika W.S.R. To Acute Fissure In Ano |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shweta Sonaji Kadam |
| Designation |
P G Scholar |
| Affiliation |
|
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalyatantra Department male and female ward and shalyatantra opd no 4
Pg research centre Gadhinglaj Kolhapur pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9834858159 |
| Fax |
|
| Email |
Shwetakadam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Chaugule |
| Designation |
Professor of shalyatantra department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502 |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department male and female ward and shalyatantra opd no 4 Gadhinglaj Kolhapur pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9975720283 |
| Fax |
|
| Email |
vinodchaugale9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Chaugule |
| Designation |
Professor of shalyatantra department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502 |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department room no 4Gadhinglaj Kolhapur pin 416502
MAHARASHTRA
416502
India |
| Phone |
9975720283 |
| Fax |
|
| Email |
vinodchaugale9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502 |
|
|
Primary Sponsor
|
| Name |
Dr Shweta Sonaji Kadam |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Sonaji Kadam |
Late kedari Redekar Dharmaday Rugnalaya Kolhapur |
Shalyatantra Male and Female ward no 1 and 2 and 3 and opd no 3
Kolhapur
MAHARASHTRA
Kolhapur
MAHARASHTRA |
9834858159
Shwetakadam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | sarpiH, सर्पिः | (Procedure Reference: Sharangdhar, Procedure details: Locally application of ghrita at the site of fissure and leaving it overnight following the same procedure for seven days.)
(1) Medicine Name: Shatdhauta ghrita, Reference: Vaidyakshabdasindhu , Route: Topical, Dosage Form: Ghrita, Dose: 2(NA), Frequency: hs, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | sarpiH, सर्पिः | (Procedure Reference: Sharangdhar, Procedure details: Application of ghrita locally at the site of the fissure and leave it overnight following this procedure every day for seven days )
(1) Medicine Name: Yashtimadhu ghrita, Reference: Ashtang sangraha, Route: Topical, Dosage Form: Ghrita, Dose: 2(NA), Frequency: hs, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from Acute fissure in ano |
|
| ExclusionCriteria |
| Details |
Patient having fissure secondary to fistula in ano, ulcerative, colitis, tuberculosis, syphilis, crohns disease other systemic disease pertaining to colo rectal in known cases
Known suspected cases of malignancy, carcinoma of anus, carcinoma of rectum
Patient suffering from infectious diseases like HIV, STD |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wheather there is significant difference between efficacy of yastimadhu ghrita and shatadhout ghrita local application in parikartika wsr to fissure in ano |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Is yastimadhu ghrita more effective than shatadhout ghrita in parikartika wsr to fissure in ano
Or
Is shatadhouta ghrita more effective than yastimadhu ghrita in parikartika wsr to fissure in ano |
7days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Fissure in Ano is most common pathology found in proctology practice. According to modern science, treatment of acute fissure-in-ano is analgesics, antibiotics, laxatives and ointment containing anaesthetic agent, vasodilator and steroids for topical use, but it has definite side effects after prolong use. Further surgical techniques like Lord’s anal dilatation, Lateral Sphincterotomy, Fissurectomy are having due risk such as incontinence and abscess formation etc. So, there was definite need to establish Ayurvedic remedy or treatment modality which proves effective and complication free. After referring the Ayurvedic texts we observed that Yashtimadhu Ghrita and Shatadhauta ghrita has Vrana Ropana, Dahashamana, Vata Pitta shaman, Vedanashamana properties which can help the fissure to heal rapidly. Yashtimadhu is considered as best drug for Vrana Ropan (wound) and it has analgesic property also. In both products base is Ghrita which itself has Samskara Anuvarti, analgesic and healing properties. So i am trying to evaluate and compare local effect of Yashtimadhu Ghrita and Shatadhauta Ghrita in management of Parikartika w.s.r. to Acute Fissure-In-Ano. |